Aimmune’s peanut allergy therapy recommended for approval by FDA committee
pharmafile | September 16, 2019 | News story | Sales and Marketing | Aimmune, FDA, peanut allergy, pharma
The FDA’s Allergenic Products Advisory Committee (APAC) has recommended the use of Aimmune Therapeutics’ AR101, also known by its proposed brand name of Palforzia, in the treatment of peanut allergy among children and teens. According to the manufacturer, the drug is designed “to reduce the incidence and severity of allergic reactions, including anaphylaxis, after accidental exposure to peanut in patients aged 4 through 17 years with a confirmed diagnosis of peanut allergy”.
It was a decisive vote from the committee, with the panel voting 7-2 that the submitted efficacy data was sufficient to recommend the drug, also voting 8-1 that the submitted safety data was adequate in combination with additional safeguards.
These efficacy data were drawn from the only Phase 3 clinical trial in which Aimmune’s drug met its primary endpoints, generating a “significant increase” in the amount of peanut protein tolerated by participants compared to placebo, while significantly reducing the incidence and severity of allergic reactions after exposure.
Around 1.6 million US children are affected by peanut allergy, making it one of the most common food allergies in the country, and allergic reactions associated with the condition can be potentially life-threatening.
“We are very pleased that APAC voted in favor of Palforzia. This is an important day for the children, teens and their families who live with the profound daily impact of peanut allergy. We look forward to continuing to work with the FDA as we move towards a potential approval of Palforzia,” said Dr Jayson Dallas, President and Chief Executive Officer of Aimmune. “We are immensely grateful to the entire food allergy community for helping us bring Palforzia one step closer to becoming the first FDA-approved treatment for any food allergy.”
Palforzia is currently under review from the FDA, with a decision expected by late January 2020.
Matt Fellows
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